PMID- 22981813
OWN - NLM
STAT- MEDLINE
DCOM- 20130409
LR  - 20121105
IS  - 1096-0295 (Electronic)
IS  - 0273-2300 (Linking)
VI  - 64
IP  - 2
DP  - 2012 Nov
TI  - An assessment of the skin sensitisation hazard of a group of polyfunctional 
      silicones using a weight of evidence approach.
PG  - 305-14
LID - S0273-2300(12)00178-X [pii]
LID - 10.1016/j.yrtph.2012.08.021 [doi]
AB  - Discordant results were observed when testing five prototype polyfunctional 
      silicone materials for skin sensitization potential in the murine local lymph 
      node assay (LLNA) and in the guinea pig maximization test (GPMT). While all five 
      silicone materials were consistently negative in the GPMT, the testing in the 
      LLNA revealed weak to moderate skin sensitisation potential for four of the five 
      test materials. Neither study quality nor other known chemical factors could 
      explain these findings. Further analysis did not provide sufficient evidence for 
      a link between the LLNA responses and the irritancy of the test substances. Only 
      in the case of one of the test materials, the occurrence of an excessive level of 
      irritation could be linked to the positive LLNA result. Considering all existing 
      information including physico-chemical and structure activity and animal data as 
      well as existing human experience from silicone exposures at the workplace or 
      their use in cosmetic products, the weight of evidence suggests that none of the 
      examined silicone materials represents a significant skin sensitization hazard to 
      humans. The suitability of the LLNA appears questionable for this class of 
      materials. In case of any additional data needs for other or new silicone 
      materials, the skin sensitization testing strategy will require careful 
      evaluation and will need to be set up on a case by case basis.
CI  - Copyright (c) 2012 Elsevier Inc. All rights reserved.
FAU - Petry, Thomas
AU  - Petry T
AD  - ToxMinds BVBA, Product Safety & Regulatory Affairs, B-1200 Brussels, Belgium. 
      thomas.petry@toxminds.com
FAU - Bosch, Axel
AU  - Bosch A
FAU - Coste, Xavier
AU  - Coste X
FAU - Dupuis, Valerie
AU  - Dupuis V
FAU - Eigler, Dorothea
AU  - Eigler D
FAU - Germain, Pierre
AU  - Germain P
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20120907
PL  - Netherlands
TA  - Regul Toxicol Pharmacol
JT  - Regulatory toxicology and pharmacology : RTP
JID - 8214983
RN  - 0 (Allergens)
RN  - 0 (Silicones)
SB  - IM
MH  - Allergens/*toxicity
MH  - Animals
MH  - Dermatitis, Allergic Contact/*etiology
MH  - Female
MH  - Guinea Pigs
MH  - Mice
MH  - Mice, Inbred CBA
MH  - Risk Assessment
MH  - Silicones/*toxicity
MH  - Skin Tests
EDAT- 2012/09/18 06:00
MHDA- 2013/04/10 06:00
CRDT- 2012/09/18 06:00
PHST- 2012/05/17 00:00 [received]
PHST- 2012/07/31 00:00 [revised]
PHST- 2012/08/27 00:00 [accepted]
PHST- 2012/09/18 06:00 [entrez]
PHST- 2012/09/18 06:00 [pubmed]
PHST- 2013/04/10 06:00 [medline]
AID - S0273-2300(12)00178-X [pii]
AID - 10.1016/j.yrtph.2012.08.021 [doi]
PST - ppublish
SO  - Regul Toxicol Pharmacol. 2012 Nov;64(2):305-14. doi: 10.1016/j.yrtph.2012.08.021. 
      Epub 2012 Sep 7.